A Phase I/II Study of the Fluorescent PARP1 Binding Imaging Agent PARPi-FL in Patients With Oral Squamous Cell Carcinomas
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 23
- 试验地点
- 7
- 主要终点
- escalating levels of toxicity (CTCAE v 4.0)
研究概览
简要总结
The purpose of this study is to test if an investigational dye, called PARPi-FL, can be used to detect this type of cancer. This will be the first time that PARPi-FL is being tried in people. First, the investigators will test the safety of PARPi-FL at different doses to find out what effects, if any, it has on people. The investigators will also see which amount of PARPi-FL is best suited to detect cancers of the mouth and tongue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 18 years old
- •Histologically or cytologically proven squamous cell carcinoma of the oral cavity or pharynx (OSCC)
- •Scheduled to undergo surgery at MSK
- •Any tumor stage, any N, M0
- •ECOG performance status 0 or 1
排除标准
- •Any surgical therapy in the area of the oral cavity or pharynx within the last 2 weeks
- •Prior or ongoing treatment with a PARP1 inhibitor
- •Known hypersensitivity to Olaparib
- •Known hypersensitivity to PEG Eligibility criteria will be assessed by an experienced oral surgeon, typically the Co-PI of the study.
研究组 & 干预措施
Fluorescent PARPi Binding Imaging Agent PARPi-FL
In the phase I of the study, increasing concentrations of PARPi-FL will be used in up to 12 patients with OSCC to determine concentration that results in the highest contrast between tumor and normal mucosa. Dose escalation will be performed in groups of three patients until image contrast decreases, side effects are noted or the concentration of PARPi-FL exceeds 1μM. Imaging will be performed in the Department of Surgery during a presurgical visit including clinical examination of the oral cavity. In the phase II part of the study the concentration of PARPi-FL determined in phase I will be used to image 18 patients with OSCC on the day of surgery. Imaging findings will be correlated with histopathologic findings in the surgically resected specimens.
干预措施: Olaparib (Drug)
结局指标
主要结局
escalating levels of toxicity (CTCAE v 4.0)
时间窗: 1 year
toxicity data relevant to study interventions (CTCAE v 4.0)
次要结局
未报告次要终点